Drug Terminology

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INTRODUCTION: The need for standards for drug terminologies has led to a collaboration between federal and non-federal organizations. Federal terminologies include the Food and Drug Administration's National Drug Code (NDC), the Structure Product Labeling(SPL)and the Unique Ingredient Identifier (UNII), the National Library of Medicine RxNorm, the National Drug File Reference Terminology ( for specific drugs)and non federal Standard Organization like the National Council for Prescription Drug Program.

NATIONAL DRUG CODE: It is Universal product Identifier for drugs intended for humans in the United States. The Drug Listing Act of 1972 mandates all drug establishments to provide the Food and Drug Administration with the list of all drugs that are prepared ,manufactures, compounded or processed for commercial distribution. The FAD publishes the NDC and information submitted in the NDC Directory which is updated daily. The national drug code is used in drugs dispensing record keeping, billing and reimbursement etc. The National Drug Code is present in medication package and inserts of prescription and nonprescription ( over-the counter)drugs. The National Drug Code is a unique 11-digit , three semi-fixed-length data fields: The first segment is the labeler code, and the other two segments are the product code and package code.

FDA Labeler Code: This is a code that is assigned by the FDA to the manufacturer, packager or re-packager of the drug as part of the application process.

Product Code: This is a code that is selected by the owner of the FDA Labeler Code. It represents the unique combination of the drug, the dosage form and strength that will be packaged by that owner. while the code is assigned by the owner of the labeler code it must be registered with the FDA.

Package Code: This is the Code that represents the package size or package grouping of the drug.

UNIQUE INGREDIENT IDENTIFIER(UNII):The United States Food and Drug Administration maintains a Substance Registration System (SRS)which identifies all substances present in drugs, biologics, devices or foods. The UNII is an identifier for a single defined substance. The UNII is one of the core components of the United States Federal Medication Terminology. It is used in the FDA's Structured Product Labeling, used in the generation of the national Library of Medicine's (NLM's)RxNorm. It is a US Government standard for drug ingredient and food allergen identifier, it is also a component of the Environmental Protection Agency's Substance Registration System.

RXNORM: It is a normalized naming system for drugs and a tool for supporting semantic interoperation between drug terminologies and pharmacy knowledge based systems. The aim of RxNorm is to allow communication of drug-related information unambiguously and effectively.

Scope of RxNorm : RxNorm contains the names of prescription and many over-the-counter drugs available in the United States. RxNorm includes generic and branded drugs:

1.Clinical drugs- pharmaceutical products given to ( or taken by ) a patient with therapeutic or diagnostic intent.

2.Drug Pack- packs that contain multiple drugs, or drugs designed to be administered in a specific sequence.

Radiopharmaceuticals, bulk powders, contrast media, food , dietary supplements, and medical devices, such as bandages and crutches , are all out of scope of RxNorm. RxNorm is produced by the National Library of Medicine.

RXCUI:RXCUI is the acronym for RxNorm Concept Unique Identifier. Drugs whose names map to the same RXCUI are taken as the same drug, identical as to the ingredients, strengths and dosage form, conversely , drugs that differ in any of these particulars are conceptually distinct and will have different RXCUI.

STRUCTURED PRODUCT LABELING (SPL): The SPL is a document markup standard approved by the Health Level Seven ( HL7) and adopted by FDA as a mechanism for exchanging product and facility information electronically.

SPL goals are to provide timely and accurate product labeling information , facilitate the review, storage and distribution of labeling contents, ensuring human readability and machine processing of labeling content, convert new and existing labeling content to XML, submit to the FDA both narrative labeling content and drug listing information, maintain consistent product information across all package, label and promotional outputs.

National Council for Prescription Drug Program ( NCPDP): It is a non-federal , not for profit , multi-stakeholder organization with members from almost al Pharmaceutical Services Industries. It is an ANSI-accredited standards such as SCRIPT standard for e-Prescribing for communication between Pharmacy and Prescribers.

The National Drug File-Reference Terminology (NDF-RT):NDF-RT is produced by the U.S Department of Veterans Affairs, Veterans Health Administration ( VHA). It is an extension of the VHA National Drug File. NDF-RT is used in modeling drug characteristics including ingredients, chemical structure, dose form , physiological effect, mechanism of action , pharmacokinetics , and related diseases. It is useful for research purposes.


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Submitted by Latifat Oyekola.